Structure and pharmaceutical formulation development of a new long-acting recombinant human insulin analog studied by NMR and MS.
PBN-AR
Instytucja
Sieć Badawcza Łukasiewicz - Instytut Biotechnologii i Antybiotyków
Informacje podstawowe
Główny język publikacji
en
Czasopismo
Journal of Pharmaceutical and Biomedical Analysis (35pkt w roku publikacji)
ISSN
0731-7085
EISSN
Wydawca
ELSEVIER SCIENCE BV
DOI
URL
Rok publikacji
2017
Numer zeszytu
Strony od-do
126–132
Numer tomu
135
Identyfikator DOI
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Autorzy
Pozostali autorzy
+ 5
Słowa kluczowe
angielski
Recombinant insulin
Pharmaceutical form
PFGSE NMR
Nanospray ESI–MS
Streszczenia
Język
angielski
Treść
A monomer structure of a novel human insulin analog A22S-B3K-B31R(SK3R) has been characterizedby NMR in water/acetonitrile solution and compared with the structure of human insulin (HIS) estab-lished in the same medium. The composition of the oligomer ensemble for neat insulins in water wasqualitatively assessed by monitoring, derived from NMR experiment, translational diffusion coefficientDi x 10−10m2s−1, whose value is a population averaged of individual coefficients for species in oligomericensemble. Nanospray ESI/MS experiment was used to establish the masses of oligomers in pharmaceu-tical formulation of the SK3R insulin. The pharmacodynamic data were established and compared toinsulin glargine characterized by the same profile of action in diabetics. The oligomerization process ofinsulin during development of pharmaceutical formulation with routinely used excipients has been stud-ied using translation diffusion coefficient Di x 10−10m2s−1established in water solution. These propertieswere compared with those of human insulin (HIS) which is a standard reference for novel recombinantinsulins.
Inne
System-identifier
PX-58a1be11d5deb89f5f8acc2d
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